Pain Control Post Colorectal SurgeryDOCIVANCT02804633
Decrease Opioid Consumption With Intra-Venous (IV) Acetaminophen After Colorectal Surgery (DOCIVA)
A study testing IV Acetaminophen in people with Pain Control Post Colorectal Surgery, run by Jewish Hospital, Cincinnati, Ohio.
Trial summary
The investigators hypothesis is that use of IV acetaminophen will significantly decrease use of post-operative opioid consumption and enhances recovery after colorectal surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Control Post Colorectal Surgery
- What is being tested?
- IV Acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient undergoing colorectal operation (Hartmann's procedure, sigmoidectomy, left hemicolectomy, right hemicolectomy, transverse colectomy, ileocecectomy, colo-colonic anastomosis, colorectal anastomosis, ileo-colonic anastomosis, low anterior resection, or abdominoperineal resection)
- Age range from 18 to 90 years old
- Patient providing signed, written informed consent before participation in the study
Who cannot join
- Patient younger than 18 years old or older than 90 years old
- Patient or family is unable to give consent
- Patient who use opioids or tramadol daily for >7 days before study medication administration(patient who, in the investigator's opinion, had or was developing opioid tolerance)
- Patient who had a chronic pain condition or any significant medical disease, laboratory abnormality, or condition that, in the investigator's judgment, could have compromised the subject's welfare, ability to communicate with the study staff, complete study activities, or otherwise restricted study participation
- Patient who had hypersensitivity to opioids, acetaminophen, or the inactive ingredients of the study medication
- Patient who had known or suspected history of alcohol or drug abuse or dependence within the previous 1 year
- Patient who had impaired liver function
- Patient who had fever within first 48 hours post-operatively and required acetaminophen for fever reduction
About this study
Official title: Decreased Opioid Consumption and Enhance Recovery With the Addition of IV-Acetaminophen in Colorectal Patients: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Study
The investigators hypothesis is that use of IV acetaminophen will significantly decrease use of post-operative opioid consumption and enhances recovery after colorectal surgery.
Read the detailed description
All patients undergoing laparoscopic and open colorectal surgery are randomized to receive either IV acetaminophen or placebo. All patients received an opioid patient controlled anesthesia (PCA). IV acetaminophen (1 gram) or placebo is given 30 minutes prior to operation and every 6 hours thereafter for up to 5 days post-operatively or discharge.
The investigators primary endpoint is to evaluate opioid consumption during the patient's hospital stay. The investigators secondary endpoints are to evaluate return of gastrointestinal function (ROGIF), time to diet ordered (TTDO), length of hospital stay (LOHS) and occurrence of ileus. Pain is measured with the pain visual analog scale score (PVASS) at 3, 8, 24 and 48 hours.
- Conditions
- Pain Control Post Colorectal Surgery
- Being tested
- IV Acetaminophen, Placebo
- Keywords
- IV acetaminophen, Colorectal Surgery, Enhance Recovery, Opioid Consumption, Pain Management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV AcetaminophenDrug
1 gram every 6 hours
PlaceboDrug
100 ml of normal saline every 6 hours
| Study group | Role | What they receive |
|---|---|---|
| IV acetaminophen group | Active comparator | In addition to PCA (morphine or hydromorphone) all patients receive 1 gram of IV acetaminophen (100 ml ) 30 minutes prior to operation and every 6 hours thereafter for up to 5 days post-operatively or discharge. Receives: Drug: IV Acetaminophen |
| Placebo Group | Placebo comparator | In addition to PCA (morphine or hydromorphone) all patients received placebo (100 ml normal saline) given 30 minutes prior to operation and every 6 hours thereafter for up to 5 days post-operatively or discharge Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption
Measured: 48 hours
pain control base on pain visual Analogue Scale Score (1-10)
Measured: 48 hours
Secondary outcomes (4)
time to Return of GI function (ROGIF) [Flatus or bowel movement]
Measured: through study completion, an average of 5 days
Time to diet ordered (TTDO)
Measured: through study completion, an average of 5 days
Length of hospital stay (LOHS)
Measured: through study completion, an average of 5 days
Occurrence of ileus
Measured: through study completion, an average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startAug 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Control Post Colorectal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jewish Hospital, Cincinnati, Ohio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir H. Aryaie, Jewish Hospital, Cincinnati, Ohio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804633
- Sponsor's protocol ID
- JH 13-04
- Acronym
- DOCIVA
- Status last verified
- Jun 2016
- First submitted
- 8 Jun 2016
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreased Opioid Consumption and Enhance Recovery With the Addition of IV-Acetaminophen in Colorectal Patients: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT02804633
- Acronym / sponsor ID
- DOCIVA / JH 13-04
- Conditions
- Pain Control Post Colorectal Surgery
- Keywords
- IV acetaminophen, Colorectal Surgery, Enhance Recovery, Opioid Consumption, Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Jewish Hospital, Cincinnati, OhioUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesis is that use of IV acetaminophen will significantly decrease use of post-operative opioid consumption and enhances recovery after colorectal surgery.
Detailed description
All patients undergoing laparoscopic and open colorectal surgery are randomized to receive either IV acetaminophen or placebo. All patients received an opioid patient controlled anesthesia (PCA). IV acetaminophen (1 gram) or placebo is given 30 minutes prior to operation and every 6 hours thereafter for up to 5 days post-operatively or discharge.
The investigators primary endpoint is to evaluate opioid consumption during the patient's hospital stay. The investigators secondary endpoints are to evaluate return of gastrointestinal function (ROGIF), time to diet ordered (TTDO), length of hospital stay (LOHS) and occurrence of ileus. Pain is measured with the pain visual analog scale score (PVASS) at 3, 8, 24 and 48 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV acetaminophen group | Active comparator | Drug: IV AcetaminophenIn addition to PCA (morphine or hydromorphone) all patients receive 1 gram of IV acetaminophen (100 ml ) 30 minutes prior to operation and every 6 hours thereafter for up to 5 days post-operatively or discharge. |
| Placebo Group | Placebo comparator | Drug: PlaceboIn addition to PCA (morphine or hydromorphone) all patients received placebo (100 ml normal saline) given 30 minutes prior to operation and every 6 hours thereafter for up to 5 days post-operatively or discharge |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient undergoing colorectal operation (Hartmann's procedure, sigmoidectomy, left hemicolectomy, right hemicolectomy, transverse colectomy, ileocecectomy, colo-colonic anastomosis, colorectal anastomosis, ileo-colonic anastomosis, low anterior resection, or abdominoperineal resection)
- Age range from 18 to 90 years old
- Patient providing signed, written informed consent before participation in the study
Key exclusion criteria (8 listed)
- Patient younger than 18 years old or older than 90 years old
- Patient or family is unable to give consent
- Patient who use opioids or tramadol daily for >7 days before study medication administration(patient who, in the investigator's opinion, had or was developing opioid tolerance)
- Patient who had a chronic pain condition or any significant medical disease, laboratory abnormality, or condition that, in the investigator's judgment, could have compromised the subject's welfare, ability to communicate with the study staff, complete study activities, or otherwise restricted study participation
- Patient who had hypersensitivity to opioids, acetaminophen, or the inactive ingredients of the study medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV Acetaminophen1 gram every 6 hours | Drug | IV acetaminophen group |
| Placebo100 ml of normal saline every 6 hours | Drug | Placebo Group |
Primary outcome
Total opioid consumption
Time frame: 48 hours
pain control base on pain visual Analogue Scale Score (1-10)
Time frame: 48 hours
4 secondary outcomes
time to Return of GI function (ROGIF) [Flatus or bowel movement]
Time frame: through study completion, an average of 5 days
Time to diet ordered (TTDO)
Time frame: through study completion, an average of 5 days
Length of hospital stay (LOHS)
Time frame: through study completion, an average of 5 days
Occurrence of ileus
Time frame: through study completion, an average of 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing IV Acetaminophen in people with Pain Control Post Colorectal Surgery, run by Jewish Hospital, Cincinnati, Ohio.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total opioid consumption (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2016.